A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

National Cancer Institute, Naples

Status and phase: Active, not recruiting; Phase 2

Conditions: Post-operative Thoracic Air Leak; Thoracic Surgery Lung

Treatments: Device: Hemopatch; Device: standard techniques used to achieve air leak control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02364791

Hemopatch

Details and patient eligibility

About

The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years

• High risk of prolonged air leak due to at least one of the following reasons:

  • Preoperative FEV1<80%
  • DLco < 80%
  • LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
  • Anticipation of intraoperative adhesions (ie, redo surgery)
  • Previous induction chemotherapy for locally advanced NSCLC
  • Chronic steroid use
  • Pleural mesothelioma

• Candidate to one of the following major thoracic surgical intervention:

  • Decortication
  • Reintervention on the same side of the previous intervention
  • Segmentectomy
  • Lobectomy with incomplete fissures on CT scan

• Written informed consent.

Exclusion criteria

• Pregnancy or breast-feeding
• Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
• Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
• Known hypersensitivity to bovine proteins or brilliant blue (FD&C Blue No.1)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

standard treatment

Active Comparator group

Description:

standard techniques to achieve air leak control after complex thoracic surgical procedures

Treatment:

Device: standard techniques used to achieve air leak control

standard treatment plus hemopatch

Experimental group

Description:

the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures

Treatment:

Device: Hemopatch

Device: standard techniques used to achieve air leak control